An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries (BO2NE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00842192

First received: February 11, 2009

Last updated: June 28, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 11, 2009

Last Updated Date

June 28, 2012

Start Date ^ICMJE

April 2009

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in number of hypoglycaemic events from baseline [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00842192 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of subjects to reach HbA1c between 6.5 and 7.0% [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
Glucose variability as measured by FPG [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
Postprandial glycaemic control as measured by PPG [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
Insulin dose and number of injections [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
Body weight [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
Number of adverse drug reactions (ADR) [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries

Official Title ^ICMJE

A Prospective, Multicentre, Multinational, Open Label, Non-controlled, Observational, 24-week Study in Patients Using Oral Anti-Diabetic (OAD) Drugs + Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Near East Region Countries

Brief Summary

This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Any subject with type 2 diabetes who is newly diagnosed or treated with OADs only is eligible for the study. The selection of the subjects as well as the treatment insulin will be at the discretion of the individual physician based on clinical judgement.

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: insulin detemir

Insulin detemir for s.c. injection, once daily, in addition to current OAD treatment. Dose to be determined by physician.

Other Names:

NN304
Levemir®

Study Group/Cohort (s)

Intervention: Drug: insulin detemir

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2154

Completion Date

August 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes who is treated with any one or more of the oral antidiabetic drug (metformin, SU, repaglinide, TZDs) is eligible for the study. The selection of the subjects will be at the discretion of the individual physician. Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

Subjects currently being treated with insulin detemir or any other insulin regimen including regular(bolus) insulin
Subjects with a hypersensitivity to insulin detemir or to any of the excipients
Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months. Women of childbearing potential who are not using adequate contraceptive methods

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel, Jordan, Lebanon, Pakistan

Administrative Information

NCT Number ^ICMJE

NCT00842192

Other Study ID Numbers ^ICMJE

NN304-3735

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Elif Coskuncay Yener, MD

Novo Nordisk Regional Office Near East

Information Provided By

Novo Nordisk

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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